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Clinical trials that are designed to help inform practice in the real world are called pragmatic trials. They are often described by their focus on practical aspects of design, including recruitment and consent, adherence and the use of standard equipment.
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Another example of a trial that is pragmatic is the Home Blood Pressure Management (HBPM) study, which used different investigators and participants from various geographical areas. This type of heterogeneity is essential for pragmatic trials to be valid and also helps reduce the chance of bias in the results. However, too much heterogeneity could cause issues with the design of the trial.
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Pragmatic trials seek to replicate real-world situations and have the highest external validity. They are typically commissioned by policy makers and practitioners to aid in their decision-making. They can be used to determine the cause-effect relationship of an intervention and
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The pragmatism idea is controversial, and there are questions about whether pragmatic trials can replace explanatory tests or if they are an addition to them. Schwartz and Lellouch1 suggested the distinction between explanation trials, which confirm the validity of a clinical or physiological hypothesis, and pragmatic trials that inform the policy and practice of. They also suggested the framework for pragmatic trials, called PRECIS.2 This tool was designed to define the elements of a pragmatic study, including the recruitment process, the design and delivery of the intervention, as well as monitoring.
The number of pragmatic trials is growing. A recent Medline search using the keywords naturalistic and pragmatic, limited to randomized controlled trials (RCTs), yielded 34 articles, which are shown in red in Figure 2. This indicates that the health science community is becoming more sensitive to the issue of pragmatics. However, it is important to remember that the majority of these studies were conducted in primary care settings.